FLUZONE AND TRIVALENT INACTIVATED INFLUENZA VIRUS VACCINE IN ELDERLY SUBJECTS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。本研究的目的是比较接种单剂量标准流感疫苗或实验性高剂量流感疫苗的受试者的反应和抗体反应。实验疫苗所含的三种流感病毒蛋白的含量大约是标准疫苗的四倍。标准疫苗和高剂量疫苗都含有美国食品和药物管理局在2004-2005年流感季节推荐的三种流感病毒蛋白。高剂量流感疫苗被认为是研究性的。受试者一般健康状况良好，至少65岁，对鸡蛋没有过敏，以前对流感疫苗没有严重反应，没有服用药物或有抑制免疫系统的潜在疾病。主要目的：疫苗接种后1个月，通过血凝抑制试验（HAI）评估的免疫原性终点为：1)在疫苗接种后约1个月，每组受试者中3种疫苗抗原的血清抗体滴度至少达到1:32 （Baylor HAI试验）的比例；2)血清抗3种疫苗抗原的HAI抗体几何平均滴度（GMT）；3)免疫前和免疫后血清样品的血清HAI抗体滴度至少增加4倍；4)接种后约1个月，3种疫苗抗原的血清HAI抗体滴度分别达到1:64和1:128 （Baylor HAI测定）的受试者比例。次要目标：反应性终点是征求的局部和全身不良事件（AE）的频率和严重程度。对于每种疫苗，将确定每组中出现任何注射部位或全身症状的受试者人数和比例，以及出现中度至重度症状的受试者比例。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this research study is to compare reactions and antibody responses in subjects who are vaccinated with either a single dose of a standard flu vaccine or the experimental high dose vaccine. The experimental vaccine includes approximately four times the amount of each of three influenza virus proteins that are in the standard vaccine. Both the standard vaccine and the high dose vaccine contain the three influenza virus proteins that were recommended by the U.S. FDA for the 2004-2005 influenza season. The high dose influenza vaccine is considered investigational. Subjects will be in good general health, at least 65 years old, no allergies to eggs, no previous severe reactions to influenza vaccines, and not taking drugs or have underlying conditions that suppress the immune system. Primary Objectives: The immunogenicity endpoints to be evaluated by haemagglutination-inhibition assay (HAI) at 1 month post-vaccination are: 1) the proportion of subjects in each group who achieve a serum antibody titer of at least 1:32 (Baylor HAI assay) for each of the 3 vaccine antigens approximately 1 month after vaccination; 2) the geometric mean titer (GMT) of serum HAI antibody against each of the 3 vaccine antigens; 3) the rates of at least 4-fold increases in serum HAI antibody titer between pre-immunization and post-immunization serum samples; and 4) the proportion of subjects who achieve serum HAI antibody titers of 1:64 and 1:128 (Baylor HAI assay) for each of the 3 vaccine antigens approximately 1 month after vaccination. Secondary Objectives: The reactogenicity endpoints are the frequency and severity of solicited local and systemic adverse events (AE). The number and proportions of subjects in each group experiencing any injection site or systemic symptoms, and the proportions of subjects who experience moderate-to-severe symptoms will be determined for each vaccine.